Mandatory Steps for Effective ISO 13485 Certification

ISO 13485:2016 specifies for a quality management system where an organization wants to prove its capability to deliver medical devices and associated services that constantly meet client and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and growth, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by sellers or external parties that provide product, including quality management system-related services to such organizations.

Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations complex in the design, production, installation and service of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help with their auditing processes.

Steps to follow during ISO 13485 Certification

To confirm medical products will pass certification, here are the key steps that organization should follow during the ISO 13485 implementation and certification:

·         Conduct a Gap Analysis:

This is an audit that controls the level of compliance versus the standards that are being held.

·         Develop a project plan:

After the audit and gap analysis, describe a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 necessities and related regional standard implementation.

·         Develop documentation:

Put together the ISO 13485 documents that includes a Quality Manual, procedures, work instructions and documentation with proof of implementation.

·         Develop & conduct training:

This is one of the most significant steps in checklist. Delivery of training to anyone who will be complicated in any stage of the production of the medical device is mandatory. The first training educates the team on appropriate requirements of the ISO 13485 standards, with those relevant to regional and product certifications. The next training is to set in place a Quality Management System that delivers a standard for complying with work instructions and required sanitary procedures, as well as recording of proof of execution on specific documentation.

·         System Implementation:

A period of three to six months is specified to implement the new Quality Management System as per ISO 13485 requirements and preparation of documentation to prove compliance.

·         Conduct an internal audit:

The dealer should conduct an internal medical device audit to measure agreement and accurate any noted deviations. Internal audit can also be performed by a third-party auditor.

·         Conduct a management review:

If the Quality Management System is not executed according to ISO 13485 procedure, and does not meet the well-defined policy and objectives, it must be adjusted to meet the essential requirements.

·         Apply for ISO 13485 certification:

An external audit of ISO 13485 is the concluding step. This external audit is typically directed by certification bodies. Based on the willingness of organization, the certification body will issue the ISO 13485 certificate if pass, or issue a non-conformance report that will need corrective actions. Once all non-conformance items are closed, the organization can then re-apply for certification.

ISO 13485 Certifications Supports Medical Device Companies:

The medical device sector is a high-pressure industry where people admiration innovation as long as it doesn’t sacrifice user safety. Moreover, creators must respond to demand spikes, as examples like the flow in ventilator needs during the COVID-19 pandemic showed. Getting an ISO 13485 certification can help a business make positive, permanent quality and process developments. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational flexibility. It’s not right for every association, but the associated advantages make it well worth consideration.

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